First Phase III glaucoma trial for NCX 470 hits goal

Once daily dosing of NCX 470 0.1% met the primary objective of non-inferiority in lowering intraocular pressure (IOP) compared to the standard of care, latanoprost 0.005%, in the 691-patient Mont Blanc Phase III clinical trial in patients with open-angle glaucoma or ocular hypertension, French ophthalmics-focussed biotech Nicox (Euronext Paris: COX) announced this morning, edging the firm’s shares up 1.9% to 2.01 euros.

Assuming regulatory approval, NCX 470 will seek a share of the glaucoma market that is expected to be worth $3.5 billion in 2030 across the USA, Japan and Europe’s top five economies.

The IOP-lowering effect from baseline for NCX 470 was 8.0 to 9.7 mmHg versus 7.1 to 9.4 mmHg for latanoprost (reduction in time-matched IOP at 8 AM and 4 PM across the week 2, week 6 and month 3 visits). In a pre-specified secondary efficacy analysis of time-matched change from baseline IOP, statistical superiority was not achieved, however the IOP reductions for NCX 470 were numerically greater than those for latanoprost at all 6 timepoints, and statistically significant (p<0.049) at 4 of the 6 timepoints.   NCX 470, a novel nitric oxide (NO)-donating bimatoprost eye drop, is currently in a Phase III clinical program.